Validation Specialist

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

QA Validation specialists represent the QA Validation department and act as a liaison between QA Validation and its internal and external customers. In this role you will apply knowledge and technical experience to complete a variety of tasks and to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

Key Responsibilities:

  • Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.
  • Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
  • Program, organize, and maintain Validation equipment and supplies including Kaye Validators, Kaye Valprobes, and train new personnel in these areas.
  • Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
  • Develop validation protocols from Validation plans and engineering documents.
  • Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations
  • Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).

Key Requirements:

  • Bachelor’s Degree with a field of study in sciences or engineering discipline preferred.
  • Significant experience within the biotech industry, preferably directly within a validation function with manufacturing experience.
  • Experience in a GMP facility, with strong knowledge of GMP regulations.
  • Working experience with temperature mapping and validation procedures.
  • Must be able to effectively multi-task and work independently, project management skills highly desired.
  • Strong communication skills and self-motivated.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if it is not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R26816